Entasis Therapeutics Announces Sulbactam-Durlobactam Expanded Access Program for Patients in the US
Entasis Therapeutics Holdings Inc. recently announced the availability of an expanded access program (EAP) for sulbactam-durlobactam or SUL-DUR, an investigational drug, for US patients with Acinetobacter baumannii infections, including carbapenem and multidrug-resistant strains.
“The ability to provide access to patients in need is consistent with the Entasis mission,” said David Altarac, MD, Chief Medical Officer. “We are excited to have in place an EAP for patients who are not eligible to participate in our study and who are suffering from a serious and life-threatening infection caused by drug resistant Acinetobacter.”
In cooperation with the FDA, expanded access, also referred to as compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. In this circumstance, Entasis Therapeutics can provide a requesting physician with pre-approval access to SUL-DUR for the treatment of the physician’s patient if specific conditions are met and there is adequate availability of drug supply.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to Expandedaccess@entasistx.com. At this time, the EAP is open to patients only in the US.
SUL-DUR is an intravenous, or IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a novel broad-spectrum IV β-lactamase inhibitor, or BLI, that we are developing for the treatment of infections caused by Acinetobacter baumannii, including carbapenem-resistant strains. We initiated ATTACK, our single Phase 3 registration trial in April 2019. ATTACK is a global Phase 3 registration trial that is actively enrolling patients at sites in 17 countries including China.
Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ pathogen-targeted design platform has produced a pipeline of product candidates, including sulbactam-durlobactam (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacteriaceae infections), and ETX0462 (targeting Pseudomonas infections). For more information, visit www.entasistx.com.
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